N/A
Completed N=279
PRESERFLO® MicroShunt Extension Study
Source: ClinicalTrials.gov NCT04333433 ↗Enrolled (actual)
279
Serious AEs
2.9%
Results posted
Mar 2024
Primary outcomePrimary: Incidence of Sight-threatening Adverse Events — 4; 0 Participants
Summary
This prospective, concurrent controlled, open-label, multicenter study is designed to collect additional safety data through 5 years of follow-up for subjects randomized to either the treatment arm (PRESERFLO® MicroShunt with MMC) or the control arm (Trabeculectomy with MMC) of the INN-005 clinical study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Sight-threatening Adverse Events |
4; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Subject has completed their Month 24 Follow-Up Visit in the INN-005 clinical study conducted under IDE G130028.
- Subject was randomized into the INN-005 study and received the PRESERFLO® MicroShunt device or trabeculectomy. (Subjects who have had the device explanted, or replaced with another device, may be included).
- Subject is willing and able to comply with all study requirements, including signing an informed consent form.
Exclusion Criteria
- Subject has exceeded the timeframe for the Month 60 Follow-Up Visit prior to enrollment for participation in this long-term follow-up study.
Data sourced from ClinicalTrials.gov (NCT04333433). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.